Prescription drug · BLA
Columvi (Glofitamab) NDC 50242-125
Glofitamab 2.5 mg/2.5mL · Solution, Concentrate · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-125-01 | 50242012501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 15, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Columvi
- Generic name (nonproprietary)
- glofitamab
- Active ingredients
- Glofitamab — 2.5 mg/2.5mL
- Dosage form
- Solution, Concentrate
- Route
- Intravenous
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761309
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)CD3 Receptor Agonists (Mechanism)CD3-directed Antibody Interactions (Mechanism)Cytochrome P450 Inhibitors (Mechanism)Increased Cytokine Activity (Physiologic effect)
- Identifiers
- Product ID 50242-125_33693fc1-cb24-4ce6-8ceb-b34ebf3536c0SPL ID 33693fc1-cb24-4ce6-8ceb-b34ebf3536c0SPL set ID 3516e753-f064-4d30-9bd5-e3f2e143f75dRxCUI 2639786, 2639792, 2639794, 2639795UNII 06P3KLK2J8
- Pharmacologic class
- Bispecific CD20-directed CD3 T Cell Engager
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450242012501followed by a unit qualifier and the quantityPackage 50242-0125-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphom…
Excerpt only. Read the full label for complete information.
About NDC 50242-125
- What is NDC 50242-125?
- 50242-125 is the product NDC for Columvi (glofitamab), Glofitamab 2.5 mg/2.5mL solution, concentrate, listed with the FDA by Genentech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Columvi (Glofitamab).
- What is the active ingredient?
- Glofitamab.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Columvi?
- 1 other product NDC are listed under this name. See all Columvi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Columvi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Columviglofitamab | Glofitamab 10 mg/10mL | ConcentrateIntravenous | Genentech, Inc. | 50242-127 | 50242-0127-01 |
Other NDCs under BLA 761309
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Columviglofitamab | Glofitamab 10 mg/10mL | ConcentrateIntravenous | Genentech, Inc. | 50242-127 |